The US Food and Drug Administration (FDA) has released draft guidance on ‘Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations’. The draft provides the Agency’s proposed recommendations for manufacturers to engage patients in multiple aspects of medical device clinical investigation design. The draft was introduced by a press statement from the FDA Acting Commissioner.
The Agency explains that the draft guidance is a reflection of its extensive work to engage patients into medical product regulatory processes, which has grown since 1991 when the FDA first began including patient perspectives in FDA Advisory Committee meetings, and which continues today through the Patient Engagement Advisory Committee (PEAC).
Through PEAC, the Center for Devices and Radiological Health (CDRH) works with a diverse group of patient organizations to encourage the inclusion of patient perspectives across the total medical device life cycle, from design to clinical investigation, through to post market monitoring. Patient preference, study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device-related quality of life or health status issues are among the topics that may be considered by the Committee.
The new draft recommends using ‘patient advisors’ to help improve medical device clinical investigations, proposing recommendations on approaches study sponsors might use to engage with patient advisors and outline some patient engagement activities that may enhance the design and conduct of clinical investigations including, for example, improving informed consent documents. The draft explains that by drawing from their personal experience, patient advisors can weigh in on outcomes that matter most to them to inform potential endpoints that are clinically meaningful in the treatment of a specific disease or condition.
FDA is requesting feedback from the patient community and study sponsors on the draft guidance by 22 November 2019.